N,N-dimethylaniline

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The Salmonella Mutagenicity Test or Ames Test for N,N-dimethylaniline found to be negative. The highest ineffective dose tested in any Salmonella typhimurium strain was 333 µg/plate.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The Salmonella Ames Test: Preincubation method

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Target gene:

histidine-manufacturing gene

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

other: histidine deficient strain

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

other: histidine deficient strain

Metabolic activation:

with and without

Metabolic activation system:

10% HLI/RLI

Test concentrations with justification for top dose:

3, 10, 33, 100, 333, 1000 µg/Plate

Vehicle / solvent:

Dimethyl Sulfoxide

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Remarks:

in the absence of S9 activation

Positive control substance:

sodium azide

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Remarks:

in the presence of S9 activation by 10% HLI/RLI

Positive control substance:

other: 2-aminoanthracene

Details on test system and experimental conditions:

RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

 Strain: TA100

Dose	No Activation  (Negative)		No Activation  (Negative)		10% HLI  (Negative)		10% HLI  (Negative)		10% RLI  (Negative)		10% RLI  (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	85	2.7	93	3.7	123	10	87	3.1	97	2.2	94	9
3	107	3.2	107	8.5			104	4.7			108	11.7
10	89	5.6	102	8	112	8.7	89	6	110	7.9	108	4.8
33	104	11.3	97	10.3	113	1.8	104	3	110	6.2	101	6.2
100	109	12.5	95	9.9	102	9.3	87	3.3	113	4.5	105	2.6
333	102	3.5	81	3.7	122	12.7	93	2.7	119	11.1	102	8.1
1000					40s	9.3			78s	13.4
Positive Control	382	7.7	345	17.7	1336	56.6	1132	40.3	461	26.6	441	9.1

Strain: TA1535

Dose	No Activation  (Negative)		No Activation  (Negative)		10% HLI  (Negative)		10% HLI  (Negative)		10% RLI  (Negative)		10% RLI  (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	23	1.9	28	3.7	9	1.9	6	0.3	8	0.6	10	1.2
3	14	0.9	20	3.8			7	1			9	0.3
10	14	3.2	21	2.2	10	1.2	7	2.8	7	0.7	8	2.2
33	16	1.5	18	1.9	8	0.3	4	1.2	6	0	7	0.7
100	15	0.3	18	2.8	6	0.3	7	0.6	7	0.9	6	1
333	15	2.1	20	2.9	7	1.2	6	1	6	1	5	0.9
1000					2s	1			3s	1.2
Positive Control	519	6.8	324	21.2	438	43	452	9.8	158	11.5	187	9.9

s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; T = Toxic; c = Contamination

Conclusions:

Interpretation of results (migrated information):
negative

N,N-dimethylaniline gives negative result for genetic toxicity in Ames test conducted on to S. typhimurium TA 100 and TA1535 with and without metabolic activation by 10% HLI/RLI S9 system.

Executive summary:

N,N-dimethylaniline gives negative result for genetic toxicity in Ames test conducted on to S. typhimurium TA 100 and TA1535 with and without metabolic activation by 10% HLI/RLI S9 system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Ames test:

The Salmonella Mutagenicity Test or Ames Test for N,N-dimethylaniline found to be negative in Salmonella typhimurium strains (TA98, TA1535 and TA100) in the presence and absence of rat and hamster liver S-9, at doses of 3, 10, 33, 100, 333 and 1000 µg/plate.

N,N-dimethylaniline was found to be negative in the Salmonella/mammalian microsome assay conducted on Salmonella typhimurium TA98, TA100, TA1537, TA1538 with and without metabolic activation by rat and hamster liver S-9 system.

Chromosome aberration:

N,N-dimethylaniline gives positive result in Chromosome Aberration test conducted on Chinese hamster Ovary (CHO) cells with and without metabolic activation by Induced Rat Liver S9 system.

N,N-dimethylaniline did not show any mutagenic activity on primary rat hepatocytes in an in vitro DNA repair test.

Justification for selection of genetic toxicity endpoint

N,N-dimethylaniline was found to be negative when tested for mutagenicity in the Salmonella/microsome preincubation assay using the standard protocol approved by the National Toxicology Program (NTP). N,N-dimethylaniline was tested in Salmonella typhimurium strains (TA1535 and TA100) in the presence and absence of rat and hamster liver S-9, at doses of 3, 10, 33, 100, 333 and 1000 µg/plate. The highest ineffective dose tested in any Salmonella typhimurium strain was 333 µg/plate.

Justification for classification or non-classification

The studies reviewed indicate that the test substance N,N-dimethylaniline is non genetoxic